Status:
COMPLETED
Model 4195 Left Ventricular (LV) Lead Chronic Performance Study
Lead Sponsor:
Medtronic
Conditions:
Heart Failure
Eligibility:
All Genders
Brief Summary
Evaluate long-term performance of the 4195 LV Lead. This evaluation is based on the number of lead-related complications occuring during the study compared to the number of leads enrolled in the study...
Detailed Description
Model 4195 LV lead complication-free survivability will be summarized.
Eligibility Criteria
Inclusion
- Patients who meet all of the following inclusion criteria and do not meet any of the following exclusion criteria are eligible for enrollment.
- Inclusion Criteria
- Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
- Patient has or is intended to receive an Attain StarFix Model 4195 LV lead
- Patient within 30 day post implant enrollment window
- Exclusion Criteria
- Patient who is, or is expected to be inaccessible for follow-up
- Patient with exclusion criteria required by local law
- Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
Exclusion
Key Trial Info
Start Date :
March 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 3 2018
Estimated Enrollment :
1322 Patients enrolled
Trial Details
Trial ID
NCT00869921
Start Date
March 1 2009
End Date
April 3 2018
Last Update
September 13 2018
Active Locations (67)
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1
Anchorage, Alaska, United States
2
Phoenix, Arizona, United States
3
Scottsdale, Arizona, United States
4
Chula Vista, California, United States